R&D Study to Evaluate Cordio's Usability and to Collect Patient Speech Utterances

Last updated: December 30, 2024
Sponsor: Cordio Medical
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

Cordio HearO

Clinical Study ID

NCT05876533
CLN0016
  • Ages > 22
  • All Genders

Study Summary

To determine the usability and technical aspects of Cordio HearO™

Eligibility Criteria

Inclusion

Major inclusion Criteria:

  1. Adults patients

  2. Diagnosed with Symptomatic Chronic Heart Failure [NYHA II-IVa (ambulatory)]

  3. At least one of the following:

  4. One ADHF hospitalization in the last 12 months

  5. One unplanned IV/SC diuretic administration in the last 6 months

  6. Two unplanned IV/SC diuretic administration in the last 12 months

  7. NTProBNP >500 pg/ml or BNP*> 150 pg/ml at screening visit

  8. Clinically stable HF

  9. Willing to participate as evidenced by signing the written informed consent.

  10. Male or non-pregnant female patient (pre-menopausal women will confirm verbally).

Exclusion

Major exclusion Criteria:

  1. Not able to read in Hebrew, Russian, Arabic, English and/or Spanish.

  2. Unable to comply with daily use of the App

  3. Major cardiovascular event

  4. Had a Cardiac Resynchronization Device (CRT) implanted or upgrading ≤ 1 month priorto screening visit.

  5. Has estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 meter square (Cockroft-Gault formula).

  6. Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.

Study Design

Total Participants: 216
Treatment Group(s): 1
Primary Treatment: Cordio HearO
Phase:
Study Start date:
March 18, 2022
Estimated Completion Date:
March 15, 2025

Study Description

The system (including App and server) will be tested under simulated use conditions with representative users to identify potential changes required to the application user interface, to improve user performance and satisfaction, and to inform future design options.

The recordings data will also be used for algorithm improvement

Connect with a study center

  • Barzilai Medical Center- Cardiology

    Ashkelon,
    Israel

    Site Not Available

  • Heart Failure Clinic - Clallit Be'er Sheva

    Be'er Sheva,
    Israel

    Site Not Available

  • Rabin Medical Center - Cardiology- CHF

    Petah tikva, 49100
    Israel

    Site Not Available

  • Kurker Family Medicine

    South Windsor, Connecticut 06074
    United States

    Site Not Available

  • C&R Research Services

    Cape Coral, Florida 33904
    United States

    Site Not Available

  • C&R Research Services

    Miami, Florida 33176
    United States

    Site Not Available

  • Lake County Med Grp

    Athens, Georgia 31024
    United States

    Site Not Available

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